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UPDATE: The FDA on Tuesday evening approved Sprout Pharma's women's libido drug Addyi (flibanserin) despite ongoing concerns about the drug's safety and efficacy. It is the first-ever drug approved for the purpose of increasing female sexual desire. And on Wednesday, Sprout CEO Cindy Whitehead announced that the company would be going on a hiring binge in anticipation of an October 17 release date for Addyi, ballooning the firm's workforce from 34 people to 200 employees.

"Today’s approval provides women distressed by their low sexual desire with an approved treatment option," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). "The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction."

Advocates and Sprout's marketing team have been pushing Addyi as a matter of basic fairness, pointing out that there is no Viagra equivalent for women and that the market is crying out for such a therapy. However, Addyi is not really a Viagra equivalent—and trials have found that its efficacy on female sexual desire is modest at best. FDA advisory panel members who ultimately recommended the drug's approval expressed concerns regarding both efficacy and possible safety concerns such as low blood pressure and fainting, especially when Addyi is mixed with alcohol. The FDA addressed this second concern in its approval by requiring prescribing doctors to warn women about the possible adverse effects of mixing the two.

Ultimately, the specter of an unmet medical need in the women's sexual medication market and a robust marketing campaign on behalf of Addyi led advisory panel members to recommend approval. And after two prior rejections, the FDA itself has now approved the medication. All eyes will be on Sprout's marketing team, as the company has had some prior brushes over its sale tactics in the past (as reported below). For its part, Sprout has said that its efforts will be primarily be focused on "educating" healthcare professionals about the drug at first.

Dive Brief:

Bob and Cindy Whitehead, the owners of Sprout Pharmaceuticals, have a history of running afoul of FDA regulations, critics of the company have pointed out. This problem dates back to March 2010 when the FDA sent the duo (who were running a company called Slate Pharmaceuticals at the time) an 11-page letter detailing their regulatory breaches.

Although many are excited about potential approval of Sprout's drug for low female libido, Addyi, others are concerned about the company's aggressive marketing tactics, including a history of overinflated claims about a previous testosterone drug.

Some critics have gone so far as to state that Addyi should not be approved due to concerns about safety and efficacy. However, there is a major push to somewhat level the therapeutic playing field for women, many of whom look at Viagra for men and wonder, "Why is there no option for my low libido?" (UPDATED ABOVE)

Dive Insight:

In 2010, the FDA's letter to Slate emphasized numerous breaches of regulatory conduct associated with promotion of its testosterone supplement, Testopel. The warning letter discussed various misleading, unsupported, and inaccurate statements that were disseminated as part of Slate's marketing materials.

Slate created a full array of marketing materials—including brochures, a website, and a video, highlighting key points—including the idea that Testopel could help improve gym workouts or increase sex drive significantly. But neither of those points are part of the drug's label. In addition, the company failed to disclose the long laundry list of risks associated with this drug, including prostate cancer, swelling, nausea, vomiting, acne, liver problems, and headache.

Despite this history and ongoing concerns about Addyi, there is a literal cacophony of voices demanding a treatment for low sex drive in women, even if the treatment isn't a true analogue to Viagra—and this advocate pressure may just push the drug across the finish line. In June, FDA advisors voted 18 to 6 recommending approval of Addyi despite expressing multiple concerns. For now, it looks like Addyi may get its FDA blessing (after two previous failed attempts) as soon as Tuesday (UPDATED ABOVE), though Sprout has agreed to hold off on television advertising for 18 months after its initial approval.